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OncoMatch/Clinical Trials/NCT05969496

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus

Is NCT05969496 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Axitinib and Pembrolizumab for renal cancer.

Phase 2RecruitingUniversity of Colorado, DenverNCT05969496Data as of May 2026

Treatment: Axitinib · PembrolizumabThe primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Disease stage

Required: Stage CT3B, CT3C (clinical TNM)

T Stage of any of the following: cT3b, cT3c, cT4

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

Has had prior treatment with any anti-programmed cell death (anti-PD-1) or programmed cell death ligand 1 (PD-L1), or an antibody targeting any other immune-regulatory receptors or mechanisms.

Cannot have received: VEGF/VEGFR inhibitor

Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR).

Lab requirements

Kidney function

Urinalysis <2+ protein. If dipstick is 3E=2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is <2g per 24 hours.

Liver function

ALT or AST above 3 times the upper limit of normal [excluded]

Cardiac function

QTc 3E=480 msec; history of MI, unstable angina, angioplasty/stenting, bypass graft, class III/IV CHF, CVA or TIA within 12 months

ALT or AST above 3 times the upper limit of normal; Urinalysis <2+ protein... QT interval corrected for heart rate (QTc) 3E=480 msec; history of any of the following cardiovascular conditions within 12 months of enrollment to the study: Myocardial infarction, Unstable angina pectoris, Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association, Cerebrovascular accident or transient ischemic attack

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Colorado Cancer Center · Aurora, Colorado
  • Hilands Ranch Hospital · Highlands Ranch, Colorado
  • Lone Tree Medical Center · Lone Tree, Colorado

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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